Abstract

In its recent review of the US Public Health Service Sexually Transmitted Disease Inoculation Study, conducted in Guatemala
from 1946 to 1948, the Presidential Commission for the Study of Bioethical Issues identified a number of egregious ethical
violations, but failed to adequately address issues associated with the intentional exposure research design in particular.
As a result, a common public misconception that the study was wrong because researchers purposefully infected their subjects
has been left standing. In fact, human subjects have been exposed to disease pathogens for experimental purposes for centuries,
and this study design remains an important scientific tool today. It shares key features with other types of widely accepted
research on human subjects and can be conducted ethically, provided certain safeguards are implemented. That these safeguards
were not implemented in Guatemala is what made that study wrong, rather than the fact of intentional exposure itself. To preserve
public trust in the clinical research enterprise, this conclusion ought to be stated explicitly and emphasised.

Footnotes

Competing interests HFL acknowledges funding from Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics,
where she is currently an Academic Fellow. From November 2010 to July 2011, she served as a senior policy and research analyst
for the Presidential Commission for the Study of Bioethical Issues. The opinions represented herein are solely her own.